DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

DAYTIME NIGHTTIME Cold and Flu by

Drug Labeling and Warnings

DAYTIME NIGHTTIME Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredients (in each Softgel) (Daytime): Purpose
• Acetaminophen 325mg: Pain Reliever/fever reducer
• Dextromethorphan HBr 10mg: Cough suppressant
• Phenylephrine HCl 5mg: Nasal Decongestant

• Active ingredients (in each Softgel) (Nighttime): Purpose
• Acetaminophen 325mg: Pain Reliever/fever reducer
• Dextromethorphan HBr 15mg: Cough suppressant
• Docylamine Succinate 6.25mg: Antihistamine

PURPOSE

Daytime

Pain reliever/fever reducer, Cough suppresant and Nasal decongestant

Nighttime

Pain reliever/fever reducer, Cough suppressant and Antihistamine

INDICATIONS & USAGE

* temporarily relieves common cold/flu symptoms:

• nasal congestion (Daytime only)
• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing (Nighttime only)

WARNINGS

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
*more than 4 doses in 24 hrs, which is the maximum daily amount for this product
* with other drugs containing acetaminophen
*3 or more alcoholic drinks every day while using this product

Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
*skin reddening
*blisters
*rash
If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
*with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
* if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

*to make a child sleep (Nighttime only).

Ask a doctor before use if you have

* liver disease
* heart disease (Daytime only)
* high blood pressure (Daytime only)
* thyroid disease (Daytime only)
* trouble urinating due to an enlarged prostate gland
* glaucoma (Nighttime only)
* persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis
* cough that occurs with too much phlegm (mucus)

Ask a doctor or a pharmacist before use if you are
* taking the blood thinning drug warfarin
* taking sedatives or tranquilizers (Nighttime only)

When using this product
Do not use more than directed. In addition when using Nighttime:
* excitability may occur, especially in children
* marked drowsiness may occur
* alcohol, sedatives, and tranquilizers may increase drowsiness
* be careful when driving a motor vehicle or operating machinery
* avoid alcoholic drinks

Stop use and ask a doctor if
* you get nervous, dizzy, or sleepless (Daytime only)
* pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days
* new symptoms occur
* fever gets worse or lasts more than 3 days
* redness or swelling is present
* cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition

If pregnant or breast-feeding,
ask a health care professional before use.

Keep out of reach of children

OVERDOSE WARNING:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
OVERDOSE WARNING:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
* take only as directed - see OVERDOSE WARNING

* do not exceed 4 doses per 24 hrs
* take softgels with water

Read each label carefully before taking Daytime and Nighttime product

	Daytime	Nighttime
adulta & children age 12 years & over	2 softgels every 4 hours	2 softgels every 6 hours
children 4 to under 12 years	ask a doctor	ask a doctor
children under 4 years	do not use	do not use

OTHER SAFETY INFORMATION

Other information
* store at room temperature between 20 - 25°C (68 - 77°F)

*avoid excessive heat, cold and humidity

INACTIVE INGREDIENT

Inactive ingredients (Daytime)
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Inactive ingredients (Nightime)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-602

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-602-12	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	11/06/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	8
Part 2	1 BLISTER PACK	4

Part 1 of 2

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr , phenylephrine hcl capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	604
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/06/2018

Part 2 of 2

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	603
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/06/2018

Labeler - Strive Pharmaceuticals Inc. (080028013)